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Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) (ABD)

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ClinicalTrials.gov Identifier: NCT02193880
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : January 8, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Saad, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hematologic Neoplasms
Graft-Versus-Host Disease
Intervention Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alpha-beta Depleted T-cell Infusion
Hide Arm/Group Description

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Period Title: Overall Study
Started 7
Completed 4
Not Completed 3
Reason Not Completed
patients did not collect enough HPC             3
Arm/Group Title Alpha-beta Depleted T-cell Infusion
Hide Arm/Group Description

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
48
(32 to 55)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female 3
Male 1
[1]
Measure Analysis Population Description: we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 2
White 2
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
Hide Description Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Time Frame From baseline and before day +100 of transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..
Arm/Group Title Alpha-beta Depleted T-cell Infusion
Hide Arm/Group Description:

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
2.Primary Outcome
Title Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
Hide Description Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
Time Frame From baseline and before day +100 of transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.
Arm/Group Title Alpha-beta Depleted T-cell Infusion
Hide Arm/Group Description:

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
Time Frame Baseline through one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alpha-beta Depleted T-cell Infusion
Hide Arm/Group Description

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

All-Cause Mortality
Alpha-beta Depleted T-cell Infusion
Affected / at Risk (%)
Total   3/4 (75.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Alpha-beta Depleted T-cell Infusion
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Graft Failure (not related to study)   2/4 (50.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Alpha-beta Depleted T-cell Infusion
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Infections and infestations   
Infection   2/4 (50.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tiffany D Hill
Organization: University of Alabama at Birmingham
Phone: 205-996-8023
EMail: tiffanydhill@uabmc.edu
Publications:
Kaplan, EL, Meier, P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association 53(282): 457-481, 1958.
Gray, RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. The Annals of Statistics, 1141-1154, 1988.
Layout table for additonal information
Responsible Party: Ayman Saad, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02193880     History of Changes
Other Study ID Numbers: UAB 1397
First Submitted: July 14, 2014
First Posted: July 18, 2014
Results First Submitted: December 17, 2018
Results First Posted: January 8, 2019
Last Update Posted: April 25, 2019